Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-19.
At a glance
Inspections
6
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jan 2024 – 19 Jan 2024 | Human Drugs | 483 | On file |
| 22 Mar 2022 – 25 Mar 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 May 2015 – 20 May 2015 | Human Drugs | Clean | |
| 18 Jul 2012 | Not recorded | 483 | On file |
| 30 Nov 2009 | Not recorded | 483 | View 483 → |
| 14 Jun 2006 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Anders W Evenson1 insp.
Nicholas T Domer1 insp.
Jesse P Romenesko1 insp.
Denise L Burosh1 insp.
Charles Cote1 insp.
Sandra A Hughes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kleen Test Products Corporation's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat